BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3851823 · Received June 5, 2014

    Report

    Report Number
    2031642-2014-00447
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 8, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF WARRANTY REPAIR. CUSTOMER PERFORM REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED DUE TO AN OXYGEN DEVICE FAILED OCCURRENCE. UPON AN OXYGEN DEVICE FAILED OCCURRENCE, THE VENTILATOR CONTINUES TO PROVIDE VENTILATORY SUPPORT TO THE PATIENT USING AN AIR GAS SOURCE. LOSS OF THE OXYGEN SOURCE CAN BE DETRIMENTAL TO A PATIENT IF THIS TYPE OF EVENT OCCURS DURING NORMAL VENTILATION MODE USE. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE CUSTOMER SERVICE SUPPORT ADVICE THE CUSTOMER TO CONNECT THE O2 TO SEE IF THE O2 IS FLOWING AND PERFORMED PERFORMANCE VERIFICATION TESTING. THE CUSTOMER FOLLOWED THE INSTRUCTION AND NO PROBLEM WAS FOUND. THE CUSTOMER TESTED THE UNIT AND PASSED ALL TESTING. THE UNIT WAS RUN FOR 5 HOURS AND NO FAILURE WAS NOTED. THE CUSTOMER RELEASE THE UNIT FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329165 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1